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Drug Development

Project Design and Implementation of Drug development programs.

Drug development is a complex and highly regulated process that typically involves several stages, including discovery, preclinical development, clinical development, regulatory approval, and commercialization. Effective project management is essential for ensuring that each stage of drug development is completed on time, within budget, and according to regulatory requirements.

SRAMAN LIFE SCIENCES project management strategy for drug development is the use of a project team, consisting of individuals from different functional areas, such as research, preclinical development, clinical operations, regulatory affairs, and commercialization. The project team is typically led by a project manager who is responsible for coordinating activities of the team, ensuring that project milestones are met, and communicating progress to stakeholders.

SRAMAN LIFE SCIENCES also takes care of another critical component of drug development project management namely risk management. As drug development is a complex, multifaceted process, there are many potential risks that could impact the success of the project. Risk management involves identifying potential risks, assessing their likelihood and impact, and developing strategies to mitigate or eliminate them. Effective risk management can help to ensure that drug development projects stay on track and meet their objectives.

SRAMAN LIFE SCIENCES in addition to project teams and risk management also uses of project management software and tools. These tools can help project managers to track project milestones, manage resources, and monitor progress. They can also facilitate communication and collaboration among project team members, stakeholders, and regulatory authorities.

SRAMAN LIFE SCIENCES for effective drug development project management also brings a thorough understanding of regulatory requirements and compliance. Regulatory agencies such as the FDA have strict requirements for drug development, and project managers must ensure that their projects meet these requirements at every stage of development. This requires a deep understanding of the regulatory landscape, as well as effective communication and collaboration with regulatory authorities throughout the drug development process.

GLP and non GLP platforms for pre-clinical studies and discovery projects on drug development

  • Pre-clinical GLP projects for drug development

    Preclinical studies are an essential step in the drug development process. These studies are conducted to evaluate the potential safety and efficacy of a drug candidate before it enters into clinical trials. Preclinical testing is typically performed in animals, and the results of these studies are used to guide the design of clinical trials and to predict the potential risks and benefits of a drug in humans.

    Good Laboratory Practice (GLP) is a set of internationally recognized standards for the conduct of non-clinical safety studies. These standards ensure the reliability, quality, and integrity of the data generated from preclinical studies. Therefore, a preclinical GLP service is an essential component of the drug development process.

    SRAMAN LIFE SCIENCES offers a range of services to pharmaceutical and biotech companies, academic institutions, and government agencies. These services include study design, animal sourcing & housing, dosing & sample collection, data analysis and interpretation, and preparation of regulatory submissions.

    SRAMAN LIFE SCIENCES will work with the client to design a study that meets their specific needs and regulatory requirements. This includes selecting the appropriate animal species and strain, determining the appropriate dose and route of administration, and defining the endpoints and parameters to be measured.

    SRAMAN LIFE SCIENCES to finalize study design will source the animals and conduct the study in accordance with GLP guidelines. This includes ensuring that the study is conducted in a controlled environment with appropriate monitoring and documentation of all procedures and data.

    SRAMAN LIFE SCIENCES throughout the study, will collect samples and data, which will be analyzed and interpreted using appropriate statistical methods. The data will then be compiled into a report that summarizes the study findings and provides recommendations for further development.

    SRAMAN LIFE SCIENCES will then assist the client in preparing regulatory submissions, including the preparation of study reports and other documentation required by regulatory agencies.

    SRAMAN LIFE SCIENCES thus allows pharmaceutical & biotech companies and academic institutions to obtain reliable and high-quality data to guide the development of their drug candidates.

  • Genomics, primarily through application of novel and next-generation sequencing techniques, have significantly contributed to drug discovery and disease biology by comparative assessment of normal and diseased-state tissues, transcription and/or expression profiling, pharmacogenomics and the discovery of biomarkers.

    SRAMAN LIFE SCIENCES genomics services provides focus on studying the entire genome of an organism or cell. This includes identifying and analyzing individual genes, as well as studying the interactions between genes and their regulatory elements. In addition the services can be used to identify genetic mutations or variations that are associated with disease, as well as to identify potential drug targets based on the genetic makeup of a particular disease. For example identification genetic mutations or variations that are associated with a particular disease, such as cancer. This information can then be used to develop targeted therapies that are designed to specifically target the mutated gene or pathway.

    SRAMAN LIFE SCIENCES genomics network provides cutting-edge genome services through our dedicated specialists and includes access to both short read and long read next generation sequencing, epigenomics, Sanger sequencing, microarrays, DNA barcoding, DNA fingerprinting as well as detailed bioinformatic data analysis.

  • Proteomics services are focused on studying the entire set of proteins produced by an organism or cell. This includes identifying and quantifying individual proteins, as well as studying their interactions and modifications. Proteomics services can be used to identify potential drug targets based on the proteins that are involved in a particular disease, as well as to develop biomarkers for disease diagnosis and prognosis.

    Metabolomics services are focused on studying the entire set of small molecules produced by an organism or cell. This includes identifying and quantifying individual metabolites, as well as studying their interactions and modifications. Metabolomics services can be used to identify potential drug targets based on the metabolic pathways that are involved in a particular disease, as well as to develop biomarkers for disease diagnosis and prognosis.

    SRAMAN LIFE SCIENCES provides proteomics services for evaluation of the function and structure of proteins to understand an organism. Both proteome and metabolome reflect the influence of environmental exposures in addition to genetic coding. Because circulating levels of proteins and metabolites are dynamic and modifiable, they are amenable to therapeutic targeting. Design and analytic considerations in proteomics and metabolomics studies can be tailored to the investigator's goals using our specialists with expertise in high end proteomics, metabolomics, lipidomics and related technology.

    SRAMAN LIFE SCIENCES proteomics and metabolomics network includes access to technology for molecular weight confirmation, protein identification, de-novo sequencing, PTM analyses, polymer analysis, high throughput protein profiling, relative protein quantification using label-free methods, quantitative proteomics using labeled methods (TMT or iTRAQ), protein complexes identification, phospho-proteomics, and glycol-proteomics, non-targeted global metabolite profiling (Metabolomics) and non-targeted global lipid profiling (Lipidomics)

    SRAMAN LIFE SCIENCES in summary provides access and expertise to high end genomics, proteomics, and metabolomics services critical for drug development. These services provide valuable insights into the genetic, protein, and metabolic factors that influence the development and progression of diseases, and can be used to identify potential drug targets and develop more effective and targeted therapies.

  • Cellular imaging services are an essential tool in drug development, providing researchers with the ability to visualize and analyze cellular processes in real-time. These imaging services typically involve the use of sophisticated microscopy techniques to observe and measure cellular responses to various drugs or treatments.

    SRAMAN LIFE SCIENCES provides common applications of cellular imaging services in drug development for evaluation of drug efficacy and toxicity. Researchers can use imaging techniques to observe the effects that a drug has on cellular structures and functions, such as changes in cell morphology, proliferation, differentiation, and signalling pathways. This information can be used to optimize drug dosing and to identify potential adverse effects before clinical trials.

    SRAMAN LIFE SCIENCES also provides application of cellular imaging services in the identification and characterization of cellular targets for drug development. By visualizing the spatial distribution and activity of specific proteins or biomolecules within cells, researchers can gain insights into their roles in disease processes and identify potential targets for drug development. Cellular imaging services can also be used to study cellular interactions and communication, such as cell-cell signalling and cell-matrix interactions. These interactions play a crucial role in many disease processes, and understanding them can help researchers develop more effective drugs that target these interactions.

    SRAMAN LIFE SCIENCES bio-imaging network includes access to state of the art super resolution microscopy for live cell imaging including with Confocal microscopy (405nm, 488nm, 561nm and 640 nm lasers) with live cell incubation chambers.

    SRAMAN LIFE SCIENCES provides access to lifetime imaging for multi-spectral, super-sensitivity, super-resolution, and fluorescence lifetime imaging applications (WLL 485 – 685 nm, 405 nm and 440 nm pulsed laser lines). This service also allows for fluorescence lifetime imaging modules and fast molecular interactions via FLIM-FRET (Forster Resonance Energy Transfer) as well as super resolution with STED (Stimulated Emission Depletion) with XY resolution down to ~40 nm, tau-STED mode, utilizing FLIM for increased resolution.

    SRAMAN LIFE SCIENCES also provides high speed-cell sorting with a fixed-alignment cuvette flow cell for high fluorescence sensitivity using 6 lasers (355nm, 405nm, 445nm, 488nm, 561nm and 633nm) detecting up to 18 fluorescent parameters plus forward and side scatter signals.